Clear Health Pass Holdings, LLC (“Clear Health Pass”) operates as a Specification Developer, developing specifications for devices distributed under its name, and is listed with the Food and Drug Administration. However, the Company does not engage in manufacturing activities.
Clear Health Pass Holdings, LLC (“Clear Health Pass”) operates as a Specification Developer, developing specifications for devices distributed under its name, and is listed with the Food and Drug Administration. However, the Company does not engage in manufacturing activities.
As a Specification Developer, the Company may also arrange for the manufacturing of devices labeled with another establishment’s
name by a contract manufacturer.
The distribution of collection kits, specimen transport, marketing, test distribution, and actual testing is performed by a high-complexity Clinical Laboratory Improvement Amendments (CLIA) lab.
All testing conducted by the CLIA lab is compliant with the Centers for Medicare and Medicaid Services (CMS) CLIA Lab Amendments Act.
Clear Health Pass™ LLC acts as Authorized Representative of tribal, federally chartered corporations formed under Section 17 of the Indian Reorganization Act (IRA), U.S.C. Title 25.
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